Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)

NCT03767543 | Completed Phase 3

• 2 other identifiers: LPS15544U1111-1215-0238
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 32

Brief Summary

Primary Objective: To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling. Secondary Objective: To gain additional information on the efficacy and safety of using a simple patient-titration protocol for administration of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in glycated hemoglobin (HbA1c)%

  Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)

  Baseline to Week 26

Secondary Outcomes (15)

• Percentage of patients achieving HbA1c ≤7% at Week 26

  At Week 26

• Change in fasting plasma glucose (FPG) from baseline to Week 12

  Baseline to Week 12

• Change in FPG from baseline to Week 26

  Baseline to Week 26

• Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12

  Baseline to Week 12

• Change in fasting SMPG from baseline to Week 26

  Baseline to Week 26

Study Arms (2)

iGlarlixi DAILY

EXPERIMENTAL

Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached

Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010

iGlarlixi WEEKLY

ACTIVE COMPARATOR

Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached

Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010

Interventions

INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

iGlarlixi DAILY; iGlarlixi WEEKLY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subject ≥ 18 years
• Patients with type 2 diabetes mellitus (T2DM) based on Diabetes Canada 2018 Clinical Practice Guidelines criteria and diagnosed at least 6 months prior to the screening visit
• Uncontrolled glycemia with an A1c ≥7.5% and ≤10.5%
• Patients treated for at least 6 months on any basal insulin (including but not limited to insulin glargine, Toujeo®, Degludec®, etc.) ± oral anti-diabetic drug (OADs)
• The total basal insulin dose must be ≤ 40 units/day
• Body mass index (BMI) between 20 kg/m2 and 40 kg/m2 inclusively

You may not qualify if:

• History of severe hypoglycemia or hypoglycemia unawareness
• History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening visit
• Current or previous (known intolerance to GLP-1s) treatment with glucagon like peptide-1 (GLP-1) receptor agonist
• Current use of rapid-acting insulin or premix insulins or use of these insulins within 3 months prior to the screening visit
• Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total duration of 1 week or more within 3 months prior to the screening visit
• Use of weight loss drugs within 3 months prior to the screening visit
• Patients with conditions/concomitant diseases that will affect safe participation in this study (e.g. active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require treatment within the study period, etc.)
• Women of childbearing potential (WOCBP) not protected by an effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
• Positive serum pregnancy test in WOCBP, pregnancy or lactation
• Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) or uncontrolled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening visit
• History of pancreatitis (unless pancreatitis was related to gallstones and treated with cholecystectomy), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, or stomach/gastric surgery
• Personal or immediate family history of medullary thyroid cancer or genetic conditions that predispose the patient to medullary thyroid cancer (e.g. multiple endocrine neoplasia syndromes)
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (32)

Investigational Site Number 1240004

Barrie, L4N4L3, Canada

Location

Investigational Site Number 1240006

Brampton, L6S0C9, Canada

Location

Investigational Site Number 1240002

Brampton, L6T4V3, Canada

Location

Investigational Site Number 1240005

Burlington, L7R1A4, Canada

Location

Investigational Site Number 1240003

Calgary, T2H2G4, Canada

Location

Investigational Site Number 1240024

Chicoutimi, G7H7K9, Canada

Location

Investigational Site Number 1240014

Concord, L4K4M2, Canada

Location

Investigational Site Number 1240017

Etobicoke, M9R4E1, Canada

Location

Investigational Site Number 1240030

Greenfield Park, J4V2G8, Canada

Location

Investigational Site Number 1240031

Halifax, B3H1V7, Canada

Location

Investigational Site Number 1240026

Hamilton, L8S4K1, Canada

Location

Investigational Site Number 1240011

Laval, H7T 2P5, Canada

Location

Investigational Site Number 1240016

London, N6A 4V2, Canada

Location

Investigational Site Number 1240015

London, N6G 4X8, Canada

Location

Investigational Site Number 1240019

Mirabel, J7J2K8, Canada

Location

Investigational Site Number 1240018

Montreal, H1M1B1, Canada

Location

Investigational Site Number 1240023

Montreal, H4A2C6, Canada

Location

Investigational Site Number 1240020

Montreal, H4A3T2, Canada

Location

Investigational Site Number 1240029

Montreal, H4T1Z9, Canada

Location

Investigational Site Number 1240027

Nepan, K2J0V2, Canada

Location

Investigational Site Number 1240025

Newmarket, Canada

Location

Investigational Site Number 1240021

Oakville, L6M1M1, Canada

Location

Investigational Site Number 1240009

Oshawa, L1H7K4, Canada

Location

Investigational Site Number 1240008

Québec, G1G3Y8, Canada

Location

Investigational Site Number 1240022

Québec, G1V4W2, Canada

Location

Investigational Site Number 1240028

Saint-Lambert, J4P2H4, Canada

Location

Investigational Site Number 1240013

Saint-Marc-des-Carrieres, Canada

Location

Investigational Site Number 1240033

Toronto, M3J0K2, Canada

Location

Investigational Site Number 1240001

Toronto, M4G3E8, Canada

Location

Investigational Site Number 1240012

Vancouver, V5Y3W2, Canada

Location

Investigational Site Number 1240007

Victoriaville, G6P6P6, Canada

Location

Investigational Site Number 1240032

Winnipeg, R2V4W3, Canada

Location

Related Publications (2)

• Yale JF, Roborel de Climens A, Aggarwal N, Dex T, Gerstein HC, Harris S, Hramiak I, Stewart J, Leiter LA. Ease of Use of the iGlarLixi SoloStar Pen from the LixiLan ONE CAN Pen Sub-Study: Questionnaire Findings from People Living with Type 2 Diabetes and Their HealthCare Providers. Diabetes Ther. 2023 Feb;14(2):377-386. doi: 10.1007/s13300-022-01353-6. Epub 2022 Dec 27.

  PMID: 36574199 DERIVED

• Hramiak I, Gerstein HC, Leiter LA, Yale JF, Bajaj HS, Stewart J, Toutounji MJ, Harris SB. Comparing a daily versus weekly titration algorithm in people with type 2 diabetes switching from basal insulin to iGlarLixi in the LixiLan ONE CAN randomized trial. Diabetes Obes Metab. 2022 Oct;24(10):1998-2007. doi: 10.1111/dom.14787. Epub 2022 Jun 29.

  PMID: 35670659 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: March 11, 2019
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (32)